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Pfizer's Herceptin Biosimilar Moving Forward Amid Rising Competition

 
• By Sten Stovall

Pfizer hopes positive top-line Phase III trial data on its Herceptin (trastuzumab) biosimilar can help it tap the lucrative market in HER2-overexpressing cancers, but analysts say that therapeutic space looks increasingly crowded with no clear favorite yet in sight.

Pfizer Inc. Dec. 1 said it was "encouraged" by good top-line results from its Phase III pivotal comparative REFLECTIONS B3271002 study of its PF-05280014 biosimilar for treating patients with HER2-positive metastatic breast cancer. The 690-patient study met its primary endpoint and was designed to measure the safety and efficacy of the biologic follow-on versus Genentech Inc.'s Herceptin (trastuzumab).

Pfizer, which is seeking new sources of revenue growth, said the Phase III trial showed equivalence in the primary end...

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Boehringer Scores First Approval For Targeted Oral Drug In HER2-Mutant NSCLC

 
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Sjögren’s Success For Ianalumab Shores Up Novartis’s Pipeline-In-A-Product Plans

 
• By Alexandra Shimmings

Novartis has strengthened its argument that ianalumab, its BAFF-R inhibitor and ADCC-mediated B-cell depletor candidate, has PIP potential with successful topline results in two Phase III Sjögren’s syndrome trials, after recently dropping the product in hidradenitis suppurativa.